Press releases

Discovery: Stopping inclusions in two treatment groups

Press release | 04 Jul 2020 - 18h29 | By INSERM PRESS OFFICE
Institutional and special event

After the inclusions in the hydroxychloroquine arm stopped, both arms testing the lopinavir/ritonavir combination with or without interferon beta were stopped in the Solidarity and Discovery clinical trials. Given the adaptive nature of the Solidarity trial and its European Discovery “daughter” trial, a reflection is underway on the evolution of the protocol. Publications in international peer-reviewed journals are in preparation concerning both the evaluation of hydroxychloroquine and lopinavir/ritonavir.

 The Solidarity and Discovery clinical trials, whose objective is to test the efficacy and safety of medicines repurposed for the indication of SARS-CoV-2 infection requiring hospitalization, announced today the definitive cessation of inclusions in the groups of patients receiving the lopinavir/ritonavir antivirals with or without interferon beta.

This decision is based on the recommendations for termination made by the independent data monitoring panels of the two trials. These were based on the lack of efficacy on mortality of hospitalised patients for the lopinavir/ritonavir compared to standard therapy. On the other hand, in the Discovery trial, which thoroughly analyzed adverse events in treated patients, the independent committee highlighted the significantly higher frequency of serious adverse events based on clinical laboratory data related to renal function in the two groups of patients receiving the lopinavir/ritonavir combination, particularly in intensive care patients. It should be added that the UK Recovery trial also stopped the lopinavir/ritonavir treatment arm for lack of efficacy.

A communication in the form of publications in international peer-reviewed journals will detail the results. In addition, given the adaptive nature of the Solidarity trial and its European “daughter” trial Discovery, a reflection is underway on the evolution of the protocol. In addition to the ongoing evaluation of Remdesivir and interferon, this includes the possibility of testing new treatments.

The pandemic linked to the SARS-CoV-2 virus responsible for Covid-19 disease continues to progress. The Solidarity global therapeutic clinical trial organized by WHO continues to include approximately 500 patients per week, particularly in South America, in the Middle East and in Asia where the epidemic remains active. The current total number of patients included in Solidarity is more than 5,500 worldwide, of which 760 patients are part of the Discovery trial. France is the 2nd largest contributor in terms of number of patients.

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Press release – Inserm press room Discovery: Stopping inclusions in two treatment groups Link : https://presse.inserm.fr/en/discovery-stopping-inclusions-in-two-treatment-groups/40087/
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